Lenvima

(Lenvatinib)

ApprovedSmall molecule

Lenvatinib is used to treat certain types of cancer including thyroid cancer, kidney cancer, and liver cancer by blocking proteins that help cancer cells grow and spread.[2] Lenvima is currently approved and in use across 110 indications[4].[1]

Lenvima is one of 1259 small molecule programs targeting Metastasis. It is currently in Approved.

110

Indications

426

Total Trials

Active Trials

1,258

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MetastasisRecruiting

Mucosal MelanomaUnknown status

Hepatocellular CarcinomaUnknown status

Ovarian CancerActive, not recruiting

Biliary Tract CancerUnknown status

Renal Cell CarcinomaCompleted

Endometrial CancerNot yet recruiting

Breast CancerNot yet recruiting

Thyroid CancerCompleted

Soft Tissue SarcomaCompleted

MetastasisPhase 2

Recruiting

Mucosal MelanomaPhase 2

Unknown status

Hepatocellular CarcinomaPhase 3

Unknown status

Ovarian CancerPhase 2

Active, not recruiting

Biliary Tract CancerPhase 2

Unknown status

Renal Cell CarcinomaPhase 3

Completed

Endometrial CancerPhase 3

Not yet recruiting

Breast CancerPhase 2

Not yet recruiting

Thyroid CancerApproved

Completed

Soft Tissue SarcomaPhase 2

Completed

Showing 10 of 110 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lenvima

Eisai

Approved

3 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Duragesic-100

CCephalon

Preclinical

2 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 9

Spravato

WWim Janssens

Preclinical

2 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1/2Not yet recruiting

Portal Vein Thrombosis

NCT05286320

Q4 2026

Phase 2Not yet recruiting

Second-Line Treatment

NCT06028633

Phase 2Active, not recruiting

Neoadjuvant

NCT05113186

Phase 3Recruiting

Sintilimab

NCT05608200

Phase 2Active, not recruiting

Hepatocellular Carcinoma

NCT05822752

Phase 2Not yet recruiting

Liver Cancer

NCT06563934

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma38 trials

Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma

Completed·RRenJi Hospital·N/A·NCT04642547·30 enrolled

Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

Completed· BeiGene logo

BeiGene·Phase 2·NCT04401800·64 enrolled

Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

Recruiting·ZZe-yang Ding, MD··NCT05713994·300 enrolled

Show 35 more trials

A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

Completed· Eisai logo

Eisai··NCT04763408·335 enrolled

Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma

Active, not recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 1/2·NCT05901194·25 enrolled

Lenvatinib Combined With TACE to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

Unknown status·FFudan University·N/A·NCT03838796·297 enrolled

Radiofrequency Ablation Combined With Toripalimab and Lenvatinib in the Treatment of Short-term Recurrent Hepatocellular Carcinoma.

Unknown status·HHenan Cancer Hospital·N/A·NCT05162898·90 enrolled

Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

Completed·SSun Yat-sen University··NCT04627012·600 enrolled

Lenvatinib Following Liver Transplantation in Patients With High-Risk Hepatocellular Carcinoma

Unknown status·RRenJi Hospital·Phase 2/3·NCT04168944·108 enrolled

A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma

Completed· Eisai logo

Eisai··NCT03663114·713 enrolled

Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma

Recruiting·HHunan Cancer Hospital·Phase 2·NCT06406634·30 enrolled

To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04443049·170 enrolled

Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

Unknown status·BBaocai Xing·Phase 2·NCT04042805·36 enrolled

A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

Completed·AAkeso·Phase 1/2·NCT04444167·59 enrolled

Assessment of the Efficacy of Lenvatinib Versus Sorafenib in the Management of Advanced Hepatocellular Carcinoma

Unknown status·—·N/A·NCT05391867·70 enrolled

Neoadjuvant Combination Therapy of Lenvatinib and TACE for Transplant-Eligible Large Hepatocellular Carcinoma Patients

Enrolling by invitation·TThe Methodist Hospital Research Institute·Phase 2·NCT05171335·50 enrolled

FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial

Recruiting·SSun Yat-sen University·Phase 3·NCT06201065·200 enrolled

A Single-Arm, Multicenter, Exploratory Clinical Study of TACE Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07131501·48 enrolled

A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma

Recruiting·IIterion Therapeutics·Phase 1/2·NCT05797805·178 enrolled

FOLFOX Plus Lenvatinib Adjuvant Therapy for Hepatocellular Carcinoma Post-Liver Transplantation

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 1/2·NCT06409637·62 enrolled

Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Unknown status·RRenJi Hospital·Phase 2/3·NCT04319484·108 enrolled

A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer

Not yet recruiting·FFudan University··NCT05660213·750 enrolled

Icaritin Soft Capsules+TACE+Immunotherapy+Targeted Therapy Versus TACE+Immunotherapy+Targeted Therapy for Unresectable Hepatocellular Carcinoma

Not yet recruiting·ZZhiyong Huang·Phase 1/2·NCT06896396·60 enrolled

The Safety and Efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody of Advanced Unresectable Hepatocellular Carcinoma

Completed·XXinrui Zhu，MD·Phase 1/2·NCT04997850·142 enrolled

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

Recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT05954897·29 enrolled

HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma

Recruiting·SSun Yat-sen University··NCT06333561·300 enrolled

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Recruiting·FFudan University·Phase 2·NCT07047586·146 enrolled

A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma

Not yet recruiting·FFudan University·Phase 2·NCT07328009·350 enrolled

Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Recruiting·TTongji Hospital··NCT05717738·300 enrolled

A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

Completed· Eisai logo

Eisai··NCT04008082·412 enrolled

Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)

Terminated· Eisai logo

Eisai·Phase 2·NCT03433703·8 enrolled

Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib as Second-line or Later Therapy in Patients With Advanced Hepatocellular Carcinoma

Unknown status·FFudan University·Phase 1·NCT05675462·25 enrolled

TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma

Not yet recruiting·TTongji Hospital··NCT07340502·364 enrolled

Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)

Completed· Eisai logo

Eisai·Phase 1/2·NCT00946153·66 enrolled

A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma

Completed· Eisai logo

Eisai·Phase 3·NCT01761266·954 enrolled

The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Unknown status·SSun Yat-sen University·Phase 3·NCT04053972·377 enrolled

Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT05822752·130 enrolled

Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma

Unknown status·SSun Yat-sen University··NCT05889949·200 enrolled

Pembrolizumab9 trials

Investigation of Predictive Biomarkers in Patients With Advanced BTC Treated With Lenvatinib Plus Pembrolizumab

Recruiting·—··NCT06648057·100 enrolled

Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors

Completed·PPeking Union Medical College Hospital·Phase 2·NCT03895970·32 enrolled

Lenvatinib and Pembrolizumab Simultaneous Combination Study

Completed·NNational Cancer Center Hospital East·Phase 2·NCT03609359·29 enrolled

Show 6 more trials

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Completed· Eisai logo

Eisai·Phase 1/2·NCT05091346·89 enrolled

Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Participants With Selected Solid Tumors

Completed· Eisai logo

Eisai·Phase 1·NCT03006887·6 enrolled

Lenvatinib and Pembrolizumab With or Without BCAA in Unresectable HCC

Not yet recruiting·FFudan University·Phase 2·NCT07412054·234 enrolled

A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors

Completed· Eisai logo

Eisai·Phase 1/2·NCT02501096·357 enrolled

Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT04976634·730 enrolled

Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy

Completed·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT05101629·32 enrolled

Lenvatinib9 trials

Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies

Recruiting·HHua Li·Phase 1·NCT05803928·70 enrolled

A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC

Not yet recruiting·AAkeso·Phase 2·NCT06984718·120 enrolled

Phase II Study of Single Agent Lenvatinib

Unknown status·NNational University Hospital, Singapore·Phase 2·NCT03168074·30 enrolled

Show 6 more trials

SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)

Not yet recruiting·SSun Yat-sen University·Phase 3·NCT05718232·136 enrolled

Lenvatinib Plus TACE Versus Sorafenib Plus TACE for HCC With PVTT

Unknown status·—·Phase 4·NCT04127396·72 enrolled

Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC

Unknown status·RRenJi Hospital·N/A·NCT05718882·30 enrolled

Lenvatinib Plus HAIC of Modified FOLFOX Regime vs Lenvatinib Plus HAIC of ROX Regime in Patients With Advanced HCC

Unknown status·ZZhejiang Cancer Hospital·Phase 1·NCT05007587·60 enrolled

Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

Recruiting·SSecond Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT06904196·78 enrolled

Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers

Completed· Eisai logo

Eisai·Phase 1·NCT02723630·60 enrolled

Thyroid Cancer8 trials

A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer

Recruiting·FFudan University·Phase 4·NCT06195228·800 enrolled

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Recruiting·WWest China Hospital·Phase 2·NCT06482086·75 enrolled

UPCC 36315 A Phase II Study Of Everolimus (RAD001) And Lenvatinib (E7080) In Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Lenvatinib Alone

Suspended·TThomas Jefferson University·Phase 2·NCT03139747·5 enrolled

Show 5 more trials

Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)

Completed· Eisai logo

Eisai··NCT02430714·629 enrolled

Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

Active, not recruiting·NNational Cancer Center Hospital East·Phase 2·NCT05696548·51 enrolled

An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer

Approved for marketing· Eisai logo

Eisai··NCT02211222

Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)

Completed·—·Phase 2·NCT02973997·57 enrolled

A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)

Terminated· Eisai logo

Eisai·Phase 2·NCT02657369·34 enrolled

Renal Cell Carcinoma7 trials

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

Terminated·CCoImmune·Phase 2·NCT04203901·16 enrolled

A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease

Completed· Eisai logo

Eisai·Phase 2·NCT02915783·41 enrolled

Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT04704219·160 enrolled

Show 4 more trials

A Study of Belzutifan (MK-6482) as Monotherapy and in Combination With Lenvatinib (E7080/MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma (MK-6482-010)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT05030506·45 enrolled

Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)

Terminated·WWashington University School of Medicine·Phase 2·NCT04267120·11 enrolled

A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04522323·67 enrolled

A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment

Completed· Eisai logo

Eisai·Phase 1/2·NCT01136733·173 enrolled

74 more indications

First-line Treatment5 trials

Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore

Recruiting·NNanfang Hospital, Southern Medical University·Phase 2·NCT06157996·92 enrolled

TACE With Lenvatinib Versus Lenvatinib Alone in in First-line Treatment of Advanced HCC

Unknown status·SSun Yat-sen University·Phase 3·NCT03905967·336 enrolled

Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC

Not yet recruiting·HHarbin Medical University·Phase 2·NCT06648525·68 enrolled

Show 2 more trials

Lenvatinib Plus Tislelizumab With or Without TACE in First-line Treatment of Unresectable HCC

Unknown status·PPeking Union Medical College Hospital·Phase 1/2·NCT05842317·60 enrolled

Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN)

Unknown status·SSun Yat-sen University·Phase 2·NCT05410197·43 enrolled

Advanced Solid Tumors5 trials

Lenvatinib Plus PD-1 Inhibitor for Advanced Solid Tumors With 11q13 Amplification

Not yet recruiting·TTongji Hospital·Phase 2·NCT07417501·60 enrolled

Eribulin and Lenvatinib in Advanced Solid Tumors

Completed·—·Phase 2·NCT02640508·29 enrolled

Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03564691·470 enrolled

Show 2 more trials

Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02720068·481 enrolled

Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors

Completed· Eisai logo

Eisai·Phase 1·NCT02686164·51 enrolled

Gastric Cancer5 trials

Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06383559·39 enrolled

Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites

Recruiting·—·Phase 1/2·NCT07149090·61 enrolled

Lenvatinib With Taxane Drugs Treatment for Advanced Gastric Cancer

Unknown status·RRuijin Hospital·Phase 1·NCT05171530·19 enrolled

Show 2 more trials

Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Gastric Cancer Liver Metastasis (CASTLE-09)

Unknown status·FFudan University·Phase 2·NCT05893056·25 enrolled

An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients with Gastric Cancer

Active, not recruiting·NNational Cancer Center Hospital East·Phase 2·NCT04745988·43 enrolled

Liver Cancer4 trials

Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer

Not yet recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1/2·NCT07282509·116 enrolled

CXD101 in Immunotherapy-related Liver Cancer

Recruiting·SStephen Chan Lam·Phase 2·NCT05873244·44 enrolled

Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)

Not yet recruiting·XXu Yong, MD·Phase 2·NCT06563934·70 enrolled

Show 1 more trial

Immunotherapy for Advanced Liver Cancer

Suspended·MMirror Biologics, Inc.·Phase 2/3·NCT05033522·150 enrolled

Head and Neck Squamous Cell Carcinoma4 trials

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT04428151·408 enrolled

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT05523323·112 enrolled

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04199104·511 enrolled

Show 1 more trial

Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03524326·24 enrolled

Cholangiocarcinoma3 trials

Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT05532059·100 enrolled

Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT05823311·80 enrolled

GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma

Recruiting·TTianjin Medical University Cancer Institute and Hospital·N/A·NCT05215665·146 enrolled

Intrahepatic Cholangiocarcinoma3 trials

Combined DEB-TACE, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

Unknown status·TTongji Hospital·Phase 2·NCT06192784·36 enrolled

Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma

Withdrawn·SSun Yat-sen University·Phase 2·NCT03801499

Two-cohort Study of Toripalimab(PD1)+Lenvatnib, or Gemox+Lenvatinib in Advanced Intrahepatic Cholangiocarcinoma

Completed·SShanghai Zhongshan Hospital·Phase 2·NCT04361331·61 enrolled

Breast Cancer3 trials

Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer

Active, not recruiting·NNational University Hospital, Singapore·Phase 1/2·NCT02562118·40 enrolled

The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.

Not yet recruiting·ZZhejiang Cancer Hospital·Phase 1/2·NCT06140576·58 enrolled

Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor

Recruiting·NNational University Hospital, Singapore·Phase 2·NCT05181033·120 enrolled

Soft Tissue Sarcoma3 trials

Lenvatinib for Advanced Bone and Soft Tissue Sarcoma

Recruiting·HHenan Cancer Hospital·Phase 2·NCT05617859·60 enrolled

Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma

Completed·NNational Taiwan University Hospital·Phase 1/2·NCT03526679·30 enrolled

Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04784247·52 enrolled

Ovarian Cancer3 trials

Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer

Completed·FFloor Backes·Phase 1·NCT02788708·26 enrolled

E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125

Terminated· Eisai logo

Eisai·Phase 1/2·NCT01133756·7 enrolled

Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT06241105·69 enrolled

PD-1antibody3 trials

Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

Withdrawn·SSun Yat-sen University·Phase 3·NCT03791918

Phase II of Lenvatinib Plus PD-1 Antibody for Advanced HCC

Withdrawn·SSun Yat-sen University·Phase 2·NCT03746249

Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC

Withdrawn·SSun Yat-sen University·Phase 3·NCT03744247

Advanced3 trials

ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07157969·300 enrolled

HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion

Not yet recruiting·PPeking University··NCT07466225·150 enrolled

bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC

Recruiting·SSun Yat-sen University·N/A·NCT06061276·40 enrolled

Melanoma3 trials

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT04305054·315 enrolled

An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

Completed· Eisai logo

Eisai·Phase 2·NCT01136967·182 enrolled

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03776136·103 enrolled

Tislelizumab3 trials

Cryoablation Combined With Tislelizumab Plus Lenvatinib in 1L Treatment of Advanced HCC (CASTLE-10)

Unknown status·FFudan University·Phase 2·NCT05897268·25 enrolled

Nocardia Rubra Cell Wall Skeleton (N-CWS) Plus HAIC, Lenvatinib and Tislelizumab in Treating Patients With Advanced HCC

Unknown status·WWan-Guang Zhang·Phase 1·NCT05533892·30 enrolled

HAIC Combine Tislelizumab and Lenvatinib in the Treatment of HCC With Type IV (Vp4) Portal Vein Tumor Thrombus (HAI-TL)

Unknown status·LLi Xiao Wei·Phase 2·NCT06210334·54 enrolled

Endometrial Cancer3 trials

Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer

Terminated·VVirginia Commonwealth University·Phase 2·NCT05263492·4 enrolled

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Completed· Eisai logo

Eisai·Phase 3·NCT03517449·827 enrolled

Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT06253494·60 enrolled

Biliary Tract Cancer3 trials

Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

Completed·PPeking Union Medical College Hospital·Phase 2·NCT04656249·46 enrolled

Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT06362317·300 enrolled

Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05935579·40 enrolled

Advanced Biliary Tract Carcinoma2 trials

Pembrolizumab in Combination With Lenvatinib in Patients With Advanced Biliary Tract Carcinoma

Completed·—·Phase 2·NCT04550624·27 enrolled

Lenvatinib Combined With PD-1 Inhibitors as First-line Treatment for Unresectable/Advanced Biliary Tract Carcinoma

Unknown status·TThe First Hospital of Jilin University·Phase 2·NCT05509478·46 enrolled

PD-1 Inhibitors2 trials

HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

Completed·FFirst Hospital of China Medical University··NCT06631326·244 enrolled

HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT

Completed·PPeking University·Phase 2·NCT05166239·66 enrolled

Safety and Efficacy2 trials

Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC

Recruiting·RRenJi Hospital·N/A·NCT06519721·15 enrolled

Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors

Terminated·HHumanity & Health Medical Group Limited··NCT04428437·17 enrolled

Liver Transplant2 trials

Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation

Completed·JJinyang Gu··NCT04415567·23 enrolled

IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation

Unknown status·RRenJi Hospital·N/A·NCT05339581·78 enrolled

Small Cell Lung Cancer2 trials

Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT04938817·110 enrolled

Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03829332·623 enrolled

Esophageal Cancer2 trials

A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT05342636·90 enrolled

A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies

Completed·NNYU Langone Health·Phase 2·NCT03321630·24 enrolled

Solid Tumor2 trials

Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid Tumor

Completed· Eisai logo

Eisai·Phase 1·NCT03009292·12 enrolled

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

Active, not recruiting· Eisai logo

Eisai·Phase 1/2·NCT04008797·301 enrolled

Metastasis2 trials

Systemic Chemotherapy Plus Lenvatinib and Toripalimab for HCC With Extrahepatic Metastasis

Unknown status·SSun Yat-sen University·Phase 2·NCT04170179·25 enrolled

Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT04700072·56 enrolled

Neuroendocrine Tumors2 trials

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT05746208·29 enrolled

Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT03290079·20 enrolled

Locally Advanced2 trials

Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy

Recruiting·AAGO Research GmbH·Phase 2·NCT05903833·42 enrolled

Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC

Active, not recruiting·UUniversität des Saarlandes·Phase 2·NCT05433116·50 enrolled

Osteosarcoma2 trials

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

Completed· Eisai logo

Eisai·Phase 2·NCT04154189·81 enrolled

Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma

Completed· Eisai logo

Eisai·Phase 1/2·NCT02432274·117 enrolled

Unresectable2 trials

HAIC+Lenvatinib+Tislelizumab vs D-TACE+Lenvatinib+Tislelizumab for Unresectable HCC

Unknown status·WWen Li·Phase 2·NCT05582278·60 enrolled

Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

Recruiting·SSecond Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT05992584·30 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03797326·611 enrolled

Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC

Unknown status·TTongji Hospital··NCT05420922·2,000 enrolled

PD-1 Inhibitor2 trials

A Study of Liposomal Irinotecan Plus 5-FU/LV HAIC With Lenvatinib and a PD-1 Inhibitor in Advanced ICC

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07432568·30 enrolled

TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT

Recruiting·SSun Yat-sen University·N/A·NCT06622031·42 enrolled

Second-line Treatment2 trials

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

Withdrawn·EETOP IBCSG Partners Foundation·Phase 2·NCT06068153

Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients

Not yet recruiting·PPeking University First Hospital·Phase 2·NCT06028633·28 enrolled

Postoperative Adjuvant Therapy1 trial

Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB

Not yet recruiting·SSecond Affiliated Hospital of Xi'an Jiaotong University·Phase 4·NCT07160361·56 enrolled

Systemic Therapy1 trial

HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

Recruiting·FFirst Hospital of China Medical University··NCT06632093·84 enrolled

Adjuvant Treatment1 trial

Pembrolizumab Plus Lenvatinib in REcurrent ccRCC Patients Failing permbroLizUmab aDjuvant trEatment

Not yet recruiting·GGruppo Oncologico Italiano di Ricerca Clinica·Phase 2·NCT07460206·108 enrolled

Neoadjuvant1 trial

Neoadjuvant and Adjuvant Lenvatinib in HCC Patients Treated by Percutaneous Ablative

Active, not recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05113186·32 enrolled

Differentiated Thyroid Carcinoma1 trial

Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas

Unknown status·CCentre Leon Berard·Phase 2·NCT03732495·35 enrolled

Sintilimab1 trial

Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC

Recruiting·SSecond Affiliated Hospital of Guangzhou Medical University·Phase 3·NCT05608200·427 enrolled

Hepatitis B Virus Infection1 trial

Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma With Hepatitis B Virus Infection

Withdrawn·SShi Ming·Phase 2/3·NCT04044651

Growth1 trial

Intra-Tumoral Vascular Growth Patterns is a Robust Indicator of Adjuvant Therapy Following Liver Resection in HCC

Active, not recruiting·CChen Xiaoping··NCT06461936·620 enrolled

Prostate Cancer1 trial

Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT04848337·45 enrolled

Lung Cancer1 trial

A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments

Completed· Eisai logo

Eisai·Phase 2·NCT01529112·135 enrolled

Esophageal Carcinoma1 trial

Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy

Not yet recruiting·TThe First Affiliated Hospital of Zhengzhou University·Phase 1/2·NCT06746961·49 enrolled

Paraganglioma1 trial

Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery

Completed·MMayo Clinic·Phase 2·NCT03008369·3 enrolled

Glioblastoma1 trial

Lenvatinib, Pembrolizumab, and Tumor Treating Fields (TTFields) for Second-line Treatment of Glioblastoma

Withdrawn·—·Phase 1/2·NCT05973903

Advanced Malignancies1 trial

Lenvatinib and Capecitabine in Patients With Advanced Malignancies

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT02915172

Rectum Cancer1 trial

Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment

Recruiting·UUniversity of Chicago·Phase 2·NCT06669572·35 enrolled

Kidney Cancer1 trial

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

Not yet recruiting·SSWOG Cancer Research Network·Phase 3·NCT07383441·718 enrolled

Esophageal Adenocarcinoma1 trial

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04662710·895 enrolled

Non-Small Cell Lung Cancer1 trial

A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03516981·245 enrolled

Patients With Advanced Solid Tumors1 trial

Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors

Unknown status·SShandong New Time Pharmaceutical Co., LTD·Phase 1/2·NCT05740215·158 enrolled

Hepatic Impairment1 trial

A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)

Completed· Eisai logo

Eisai·Phase 1·NCT02421042·14 enrolled

Metastatic Cancer1 trial

Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer

Active, not recruiting·SSalubris Biotherapeutics Inc·Phase 1/2·NCT05620134·263 enrolled

Mucosal Melanoma1 trial

Lenvatinib and Pembrolizumab in Resectable Mucosal Melanoma

Unknown status·PPeking University Cancer Hospital & Institute·Phase 2·NCT04622566·26 enrolled

Portal vein thrombosis1 trial

Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.

Not yet recruiting·NNational Taiwan University Hospital·Phase 1/2·NCT05286320·27 enrolled

Solid Tumors1 trial

Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

Recruiting·33D Medicines (Sichuan) Co., Ltd.·Phase 1/2·NCT05024214·170 enrolled

Chemotherapy1 trial

Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study

Recruiting·SShanghai Junshi Bioscience Co., Ltd.·Phase 3·NCT05342194·480 enrolled

Advanced Stage1 trial

Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC

Recruiting·HHumanity & Health Medical Group Limited·Phase 2·NCT03899428·30 enrolled

Endometrial Carcinoma1 trial

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03884101·842 enrolled

Pancreatic Cancer1 trial

An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC

Unknown status·—·Phase 1/2·NCT05327582·65 enrolled

Monotherapy1 trial

Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC

Not yet recruiting·LLion TCR Pte. Ltd.·Phase 2·NCT05195294·55 enrolled

Cervical Cancer1 trial

Zimberelimab Plus Lenvatinib After Progression on Prior Immune Checkpoint Inhibitors for Advanced Cervical Cancer

Active, not recruiting·SSun Yat-sen University·Phase 2·NCT05824468·30 enrolled

Cancer1 trial

OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults

Unknown status·UUniversity Medical Center Groningen·Phase 4·NCT05949424·30 enrolled

Brain Metastases1 trial

Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05064280·104 enrolled

Leptomeningeal Metastases1 trial

Pembrolizumab And Lenvatinib In Leptomeningeal Metastases

Terminated·MMassachusetts General Hospital·Phase 2·NCT04729348·10 enrolled

Renal Impairment1 trial

A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT02199379·26 enrolled

Gastrointestinal Stromal Tumor1 trial

Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure

Completed·CCentre Leon Berard·Phase 2·NCT04193553·77 enrolled

Antibody-Drug Conjugate1 trial

A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types

Recruiting· Eisai logo

Eisai·Phase 1/2·NCT04300556·182 enrolled

Neoadjuvant Therapy1 trial

TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 2/3·NCT05250843·90 enrolled

Biliary Tract Carcinoma1 trial

Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma

Not yet recruiting·YYunpeng Liu·N/A·NCT06463548·30 enrolled

Clinical Trial1 trial

CARE1 Pragmatic Clinical Trial

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT06364631·1,250 enrolled

Liver Resection1 trial

Adjuvant Sintilimab Plus Lenvatinib for HCC Characterized With VETC Following Liver Resection

Not yet recruiting·WWan-Guang Zhang·N/A·NCT07077798·234 enrolled

Treatment1 trial

Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

Recruiting·TTianjin Medical University Second Hospital·Phase 2·NCT06739395·300 enrolled

Drug1 trial

Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem

Not yet recruiting·EEvergreen Therapeutics, Inc.·Phase 2·NCT05106127·28 enrolled

Unspecified1 trial

An Open Label Dose Escalation Study Of E7080

Completed· Eisai logo

Eisai·Phase 1·NCT00121719·82 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 13, 2015

LENVIMA

NDA NDA206947

Oct 16, 2015

LENVIMA

NDA NDA206947

Apr 22, 2016

LENVIMA

NDA NDA206947

May 13, 2016

LENVIMA

NDA NDA206947

Jul 31, 2017

LENVIMA

NDA NDA206947

Jun 6, 2018

LENVIMA

NDA NDA206947

Aug 15, 2018

LENVIMA

NDA NDA206947

Dec 7, 2018

LENVIMA

NDA NDA206947

Sep 17, 2019

LENVIMA

NDA NDA206947

Feb 20, 2020

LENVIMA

NDA NDA206947

Apr 23, 2020

LENVIMA

NDA NDA206947

Sep 14, 2020

LENVIMA

NDA NDA206947

Nov 10, 2020

LENVIMA

NDA NDA206947

Dec 18, 2020

LENVIMA

NDA NDA206947

Jul 21, 2021

LENVIMA

NDA NDA206947

Aug 10, 2021

LENVIMA

NDA NDA206947

Dec 19, 2021

LENVIMA

NDA NDA206947

Aug 5, 2022

LENVIMA

NDA NDA206947

Nov 10, 2022

LENVIMA

NDA NDA206947

Oct 23, 2023

LENVIMA

NDA NDA206947

Apr 3, 2024

LENVIMA

NDA NDA206947

Jun 7, 2024

LENVIMA

NDA NDA206947

Nov 20, 2024

LENVIMA

NDA NDA206947

Jan 29, 2025

LENVIMA

NDA NDA206947

Sources

References

[1]
ClinicalTrials.gov — 426 trial records for Lenvatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lenvima drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lenvatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lenvatinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206947). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lenvima. U.S. Food & Drug Administration.
[7]
PubMed — 2 publications indexed for Lenvatinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Multi-Kinase VEGFR Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eisai

Patent Landscape[6]

Patent Cliff

Mar 19, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7253286Oct 24, 2025

7253286*PEDApr 24, 2026

7612208Sep 19, 2026

7612208*PEDMar 19, 2027

9006256Jul 27, 2027

15 more patents

9006256*PEDJan 27, 2028

12508313Oct 4, 2030

12508313*PEDApr 4, 2031

10407393Aug 26, 2035

10259791Aug 26, 2035

11186547Aug 26, 2035

11090386Feb 23, 2036

10259791*PEDFeb 26, 2036

10407393*PEDFeb 26, 2036

11186547*PEDFeb 26, 2036

12083112Mar 3, 2036

11090386*PEDAug 23, 2036

12083112*PEDSep 3, 2036

12226409May 15, 2038

12226409*PEDNov 15, 2038

Key Publications[7]

Lenvatinib Plus Pembrolizumab First-Line in HCC: LEAP-002

Lancet OncolApr 10, 2023DOI: 10.1016/S1470-2045(23)00083-4

Lenvatinib Plus Pembrolizumab in Advanced Endometrial Cancer: KEYNOTE-775

N Engl J MedFeb 3, 2022DOI: 10.1056/NEJMoa2201517